- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01101347
A Feasibility Study of the Surpass Aneurysm-Embolization System in Intracranial Arteries
26. november 2010 opdateret af: Surpass Medical Ltd.
The purpose of this study is to evaluate safety and performance of the Surpass Aneurysm-Embolization System.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
10
Fase
- Fase 1
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Subject understands the nature of the procedure and provides written informed consent.
- Subject is willing to return to the investigational site for the thirty day and six month follow-up evaluations.
- Age 18 years to 80 years.
- Subject with a non-ruptured saccular, or fusiform intracranial aneurysm arising from a parent vessel with a diameter of > 2mm and < 6mm.
Exclusion Criteria:
- Pregnancy
- Enrollment in another trial
- Allergy or contraindication to aspirin, clopidogrel, heparin, local or general anesthesia
- History of life threatening allergy to contrast dye.
- Major surgery within previous 30 days or planned in the next 90 days after enrollment date.
- Severe neurological deficit that renders the patient incapable of living independently
- Dementia or psychiatric problem that prevents the patient from completing required follow up
- Co-morbid conditions that may limit survival to less than one year
- Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis, or intracranial vasospasm not responsive to medical therapy.
- Subject with an intracranial mass (tumor (except meningioma), abscess, or other infection), or is undergoing radiation therapy for carcinoma or sarcoma of the head or neck region.
- Subject has a history of bleeding diathesis or coagulopathy, international normalized ratio (INR) greater than 1.5, or will refuse blood transfusions.
- Subject has a serum creatinine level greater than 2.0 mg/dL (within 7 days of procedure) which the investigator determines restricts the use of contrast agents.
- Subject has a previously implanted intracranial stent associated with the symptomatic distribution within the past 12 weeks prior to enrollment date
- Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to enrollment date
- Subject has a previously implanted carotid stent associated with the symptomatic distribution within the past 12 weeks prior to enrollment date
- Subject has uncontrolled atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms.
- Subject had a subarachnoid hemorrhage within 12 weeks prior to the enrollment date.
- Subject with resistance to ASA and/or Clopidogrel.
- Subject with two or more aneurysms in associated distribution - unless the device is used to treat both aneurysms.
- Subject has a non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm.
- Target aneurysm is expected to require more than one device.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Aneurysm-Embolization System
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Vipul Gupta, MD, Medanta, Medcity
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Datoer for studieregistrering
Først indsendt
8. april 2010
Først indsendt, der opfyldte QC-kriterier
8. april 2010
Først opslået (Skøn)
9. april 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
30. november 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. november 2010
Sidst verificeret
1. november 2010
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SP-03
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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